乙型肝炎功能性治愈新药临床价值评价标准的探讨OA

China bears a substantial disease burden of chronic hepatitis B(CHB).Under current clinical management regimens for CHB,achieving functional cure(also termed clinical cure)is the core goal for the treatment of patients meeting treatment indications.To achieve the goal of functional cure,drug regulatory authorities in China and globally have successively issued technical criteria to provide guidance for the overall design and scientific evaluation of clinical trials for innovative drugs.However,the rapid development in scientific research,clinical practice,and new drug research and development in this field has brought new challenges,especially those concerning the assessment of the clinical value of investigational drugs.This article reviews the current status of clinical research and development of new drugs for achieving the functional cure of CHB worldwide,analyzes the characteristics of available clinical trial data,and focuses on key aspects of pivotal clinical trials for CHB functional cure drugs,including target populations(baseline HBsAg level),HBsAg seroclearance response,HBsAg seroreversion after drug withdrawal,and clinically meaningful target threshold of functional cure response rate,in order to provide a reference for further refinement of related technical criteria.